Biotech Archieven

Commissioning & qualification of new fill & finish / CQ lab facility

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Client: Novasep
Location: Belgium (South)
Completion: 2019 -
Total Investment Cost: ca. 10m €
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Implementation of new Green Field Aseptic Fill & Finish /QC Lab facility (1800m²), dedicated to the aseptic filling of a wide range of biological products (viral vectors, viruses, monoclonal antibodies and other biologicals). This new Fill and Finish unit features semi-automatic and automatic liquid filling machines under isolator. Also visual inspection and QC lab activities and foreseen in this new facility.

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Commissioning and Qualification (including project qualification strategy, URS, Risk Analysis, FAT, SAT, IOPQ, CSV).

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Utilities/ Facilities: HVAC, Purified Water distribution, Clean gasses (Compressed Air, CO2, O2, N2) distribution

Equipment: Filling Line, Isolator, Autoclave, LAFs, Freezers, Incubators, Cold rooms, Biosafety Cabinets

Automation: AMS, EMS, Interlocking

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by Heleen Vandermeeren

Qualification of serialization packaging system

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Client: Confidential
Location: Belgium
Completion: 2018
Total Investment Cost: Confidential
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Development of Global Validation Strategy and deployment for serialization packaging systems (IT and equipment systems).
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CSV expertise Commissioning/Qualification/Validation.
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by Heleen Vandermeeren

Transformation of a batch decontamination station

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Client: Confidential
Location: Belgium (Brussels)
Completion: 2018
Total Investment Cost: Confidential
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Transformation of a decontamination station from batch to continuous decontamination. Trouble shooting of all remaining maintenance problems in a new Product Manufacturing unit.
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Concept study, Detail engineering, Procurement, Construction Management and Commissioning/Qualification.
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HVAC, Clean Utilities, Electrical, Chemical.
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by Heleen Vandermeeren

Commissioning & qualification of new viral vector production unit

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Client: Novasep
Location: Belgium (South)
Completion: 2019
Total Investment Cost: ca. 27m€
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Implementation of new Green Field Viral Vector Production facility, including 2 cGMP production units. One unit is dedicated to adherence cell culture for viral vectors in moderate quantities (to treat certain rare diseases or for lower dose indications and one unit for suspension cell culture with bioreactors up to 2000L to produce larger quantities.
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Commissioning and Qualification (including project qualification strategy, URS, Risk Analysis, FAT, SAT, IOPQ, CSV).
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Utilities/ Facilities: HVAC, Purified Water production and distribution, Clean gasses (Compressed Air, CO2, O2, N2) production and distribution

Process Equipment: Bioreactors, Clarification skids, (Ultra)filtration skids, chromato skids, buffer prep skids

Automation: AMS, EMS, Interlocking

Support Equipment: Decontamination System, Decontamination autoclave, Sterilisation autoclave, LAF cabinets, Biosafety Cabinets
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by Heleen Vandermeeren

Commissioning & qualification of new vaccine production unit

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Client: Confidential
Location: Belgium (Brussels)
Completion: 2018
Total Investment Cost: ca. 65m€

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Implementation of new Vaccine production unit in an existing facility. Increase of capacity from 34 to 56 million doses.

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Assistance of General contractor Vinci group for commissioning/qualification and document management activities.

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Clean Utilities (Purified Water; Water for Injection, Pure Steam, Compressed Air, NaOH, Biowaste, Process Drain systems).

Process Equipment (Media - buffer prep vessels, media hold vessels, buffer hold vessels, pooling vessels, final filtration, clarification)

Process automation

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by Heleen Vandermeeren